Catalog Number

-

Brand Name

ST AIA-PACK LH II CALIBRATOR SET

Version/Model Number

N/A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

9dd39c5b-2b68-45c2-9912-45c0a8e4e6d8

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Package DI Number

14560189211657

Quantity per Package

6

Contains DI Package

04560189211650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-